TORONTO, April 04, 2019 (GLOBE NEWSWIRE) -- Profound Medical Corp. (TSX:PRN; OTCQX:PRFMF) (“Profound” or the “Company”), the only company to provide customizable, incision-free therapies which combine real-time Magnetic Resonance imaging (“MRI”), thermal ultrasound and closed-loop temperature feedback control for the radiation-free ablation of diseased tissue, today announced positive topline results from the TACT (TULSA-PRO® Ablation Clinical Trial) pivotal study designed to support its application to the U.S. Food and Drug Administration (“FDA”) for 510(k) clearance to market TULSA-PRO® in the United States.

TACT, a prospective, open-label, single-arm pivotal clinical study, enrolled 115 patients with biopsy-proven, organ-confined prostate cancer across 13 research sites in the U.S., Canada and Europe. Primary and key secondary endpoints are determined at 12 months post-treatment, but patient quality of life and disease control will be followed per-protocol to 5 years. The median age of enrolled patients was 65 years and the median Prostate-Specific Antigen (“PSA”) level was 6.3 ng/ml. The study focused on a clinically significant prostate cancer population, where 67.0% (77 out of 115) had NCCN intermediate-risk disease, and 62.6% (72 out of 115) had Grade Group 2 (GG2) or Gleason Score 7 (GS7) disease. Of the 43 patients with GG1 or GS6 disease, 60.5% (26 out of 43) had high-volume disease (≥ 3 cores positive, or ≥ 50% cancer core length). Treatment intent was whole-gland ablation with sparing of the urethra and urinary sphincter. Median targeted prostate volume was 40 cc with treatment delivery time of 51 minutes. A median of 97.6% of the prescribed target volume was heated to ablative temperatures with spatial ablation precision of ±1.4 mm measured on MRI thermometry during treatment.

The primary efficacy endpoint of TACT is the proportion of patients achieving a post-treatment PSA reduction ≥ 75% of their pre-treatment baseline value. The FDA-approved protocol’s pre-established performance goal for the success proportion was 50% of patients. In the TACT trial, the median PSA reduction was 94.9% (nadir 0.34 ng/ml), and 95.7% of patients (110 out of 115) achieved the PSA reduction endpoint.

Secondary efficacy endpoints include prostate volume reduction on 12-month MRI and histological response on 12-month 10-core prostate biopsy. The median perfused prostate volume of patients in TACT decreased from 41 cc to 4 cc, based on assessment from the local research sites, pending review by a central radiology core lab. Of the 115 patients enrolled in the study, only 4 (3.5%) did not undergo follow-up biopsy, in all cases due to patient refusal. Among 68 men with pre-treatment intermediate-risk GG2 disease, 54 (79.4%) were free of GG2 disease on one-year biopsy. Among 94 men with pre-treatment GG2 or high-volume GG1 disease, 72 (76.6%) were free of GG2 or high-volume GG1 disease on follow-up biopsy. Of the 111 men with one-year biopsy data, 72 (64.9%) had a complete histological response with no evidence of any cancer, and 16 (14.4%) had low-volume GG1 disease which has virtually no potential for metastases or cancer-related mortality1,2. The 20.6% rate of residual clinically significant prostate cancer in an intermediate-risk patient population is similar or better than that reported in prospective studies of modern external beam radiation therapy and other ablation technologies3,4. In addition, the TACT patients remain amenable to re-treatment with TULSA-PRO® or standard of care therapies.

The primary safety endpoint of TACT is the frequency and severity of adverse events graded according to the Common Terminology Criteria for Adverse Events, or CTCAE. The rate and nature of attributable adverse events were similar to the favorable safety profile reported in the Phase I Safety & Feasibility Study5 of TULSA-PRO®. In the TACT study, attributable serious adverse events occurred in 7.0% of patients, including 4.3% genitourinary infection, 0.9% urinary retention, 0.9% urinoma, 0.9% ileus (related to urinary catheter), 0.9% deep vein thrombosis, and 0.9% urethral stricture, all resolved. Similarly, 7.8% of patients experienced an attributable severe (Grade 3) adverse event, all resolved. There was no rectal injury or fistula, and no attributable Grade ≥ 4 adverse events.

Additional secondary endpoints of TACT focus on functional side effects commonly associated with current prostate cancer therapies, such as erectile dysfunction and urinary incontinence. At 12 months, 23.5% of patients had moderate erectile dysfunction (surgeon assessed Grade 2 adverse event, intervention such as medication indicated) and no patient experienced severe erectile dysfunction (Grade 3, intervention such as medication not helpful). Erectile function was also evaluated using the International Index of Erectile Function (“IIEF”) Patient-Reported Questionnaire. The median change in IIEF-5 was a decrease in 3 points, less than the minimal clinically important difference in erectile function6. At 12 months, 75.0% (69 out of 92) of previously potent patients were able to maintain erections sufficient for penetration (IIEF question 2 ≥ 2). With respect to urinary function, 2.6% of patients had moderate urinary incontinence (surgeon assessed Grade 2 adverse event, pads indicated) at 12 months. Urinary function was also evaluated using the Expanded Prostate Cancer Index Composite (“EPIC”) Patient-Reported Questionnaire. At 12 months, there was 99.1% (111 out of 112) preservation of urinary continence (≤1 pad/day), and a 96.2% rate of leak-free continence (leak <1 time/day).

Detailed results from TACT will be shared as a late-breaking abstract presentation during the American Urological Association’s (“AUA”) 2019 Annual Meeting Plenary Program being held May 3-6, 2019 in Chicago, IL. Profound will also be exhibiting at booth #4831.

“Positive outcomes from TACT are very encouraging for this population with organ-confined prostate cancer,” said Dr. Scott Eggener, Chief Investigator of the TACT study, and Director of the Prostate Cancer Program at the University of Chicago. “The TACT study easily met its primary endpoint of PSA reduction in 96% of patients, with low rates of severe toxicity and residual clinically significant GG2 disease. These findings are meaningful since the majority of patients enrolled had intermediate-risk prostate cancer. Given these positive TACT results and the ability to customize treatment based on real-time MR images, I believe there is a significant population of men with prostate cancer who may be well-suited for treatment with TULSA-PRO®. I am looking forward to presenting the complete 12-month TACT data at this year’s AUA annual meeting in Chicago.”

“I have been investigating MRI-guided TULSA for the ablation of prostate cancer for over ten years, since its early development at Sunnybrook Research Institute in Toronto,” said Dr. Laurence Klotz, Chair of Prostate Cancer Research at Sunnybrook Health Sciences Center. “I am delighted to be part of the TACT study and experience first-hand, through my patients, the favorable safety profile offered by TULSA and its low impact on patient quality of life. Considering the high sampling density of the follow-up biopsy in such small prostates, the rate of residual GG2 cancer is impressive and reflects a key benefit for intermediate-risk patients. Of the positive biopsies after TULSA, about 40% were non-metastasizing low-volume GG1, which we know lack most molecular hallmarks of cancer. This is similar to the pre-treatment setting, where these concepts were central to developing active surveillance for low-risk prostate cancer patients.”

“The TACT study demonstrated that treatment with TULSA-PRO® provides safe and effective prostate tissue ablation, with little impact on men’s functional ability compared to well-established treatment modalities such as radical prostatectomy and radiation therapy,“ said Dr. Christian Pavlovich, Director of Urologic Oncology at Johns Hopkins Bayview Medical Center. “The study also demonstrated a superior risk-benefit profile compared to other ablative approaches, including whole-gland HIFU and cryotherapy. Twelve months after TULSA, my patients are all doing well, are delighted with their quality of life, and do not have any residual GG2 or worse disease. I believe that based on these positive TACT results and the inherent flexibility of TULSA-PRO® as a surgical tool, should clearance in the United States be obtained from the FDA, TULSA-PRO® has the potential for quick acceptance and adoption by urologists.”

“MRI is transforming the continuum of care in prostate cancer, from tumor visualization and improved diagnostics, to image-guided therapy and post-treatment follow-up,” said Dr. Katarzyna Macura, Assistant Director of the Johns Hopkins ICTR Imaging Translational Program and Director of Prostate MR Imaging. “MRI-guided TULSA exemplifies the interdisciplinary synergy possible in today’s precision management of localized prostate cancer. The resolution and detail offered by real-time MRI and the TULSA-PRO® allowed the creation of customized treatment plans that have truly benefited the patients, with outcomes that are reflected in the TACT study data.”

“We are pleased to announce these positive topline results from TACT contemporaneously with the abstract being published online by the AUA,” commented Arun Menawat, Profound’s CEO. “We look forward to the presentation of the full TACT data at AUA 2019, and plan to file the 510(k) application with the FDA for TULSA-PRO® by the end of the second quarter.”

Profound develops and markets customizable, incision-free therapies for the ablation of diseased tissue.

Profound is commercializing TULSA-PRO®, a novel technology that combines real-time MRI, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. TULSA-PRO® is designed to provide customizable and predictable radiation-free ablation of a surgeon-defined prostate volume while actively protecting the urethra and rectum to help preserve the patient’s natural functional abilities.

TULSA-PRO® is CE marked and commercially launched in key European and other CE mark jurisdictions. TULSA-PRO® is demonstrating to be a flexible technology in customizable prostate ablation, including intermediate stage cancer, localized radio-recurrent cancer, retention and hematuria palliation in locally advanced prostate cancer, and the transition zone in large volume benign prostatic hyperplasia (“BPH”).

Profound has completed enrollment and 12-month follow-up in a multicenter, prospective clinical trial, TACT, which is expected to support its application to the U.S. FDA for approval to market TULSA-PRO® in the United States.

Profound is also commercializing Sonalleve®, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids and palliative pain treatment of bone metastases. Sonalleve® has also been approved by the China Food and Drug Administration for the non-invasive treatment of uterine fibroids. The Company is in the early stages of exploring additional potential treatment markets for Sonalleve® where the technology has been shown to have clinical application, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy.

Forward-Looking Statements

This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, uterine fibroids and palliative pain treatment. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the company, including risks regarding the pharmaceutical industry, economic factors, the equity markets generally and risks associated with growth and competition. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law.

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